Methods
The study was sponsored by the University of East Anglia (UEA) and
funded by the Anthony Long and Bernice Bibby Trusts. Ethical approval
was granted by the Oxford C Research Ethics Committee (Ref:
07/H0606/100).
Study
Design
Participants and Data
Sources
Prospective participants were identified for recruitment at ENT
outpatient clinics at 30 participating centres. Patients with CRS were
examined by an ENT clinician and classified into different CRS
phenotypes; chronic rhinosinusitis without polyps (CRSsNPs), chronic
rhinosinusitis with nasal polyps (CRSwNPs) or allergic fungal
rhinosinusitis (AFRS) as per EPOS 2012 criteria16 (see
CRS participant section below). Healthy controls were recruited from
family members of patients attending ENT clinics as well as members of
hospital staff at recruitment sites.
Questionnaires were completed during the clinic visit or taken home to
be completed and returned by prepaid post. No participant identifiable
data was captured therefore consent was not required although it was
implied through return of the questionnaire. Returned questionnaires
were scanned and the data imported into in an electronic database in
Microsoft Excel. Records in the database were compared to physical
copies of the questionnaires by two members of the research team to
ensure accuracy and consistency between the two.
All CRS participants and healthy controls were required to meet the
inclusion/ exclusion criteria outlined below:
CRS
Participants
Inclusion
Criteria
Criteria for diagnosis of CRS with or without polyps (EPOS
guidelines)16
At least two symptoms must be present for at least 12 weeks and include:
- One of either nasal blockage/obstruction/congestion and/or nasal
discharge (anterior/posterior nasal drip)
- and either facial pain/pressure and/or reduction or loss of sense of
smell
and additionally:
- endoscopic signs of polyps and/or mucopurulent discharge primarily
from middle meatus and/or oedema/mucosal obstruction primarily in
middle meatus
- and/or CT changes: mucosal changes within the ostiomeatal complex
and/or sinuses
Patients were then classified as having CRSwNPs, CRSsNPs or AFRS. Those
patients with the latter additionally adhered to either the Bent and
Kuhn
criteria17or the modified Vancouver
criteria.18
Healthy Control Participants
Exclusion
Criteria
- Prior history of recurrent acute or chronic rhinosinusitis.
- Any other nose/sinus disorders e.g. allergic rhinitis (hayfever).
- Any active medical problems that have required a hospital visit within
the last 12 months.
Exclusion Criteria for Both
Groups
- Patients/controls unable to comprehend written English.
- Patients/controls under the age of 18 years.
Quantitative Variables and
Bias
A specific question on smoking was included in the questionnaire as
follows: